Effect of Finishing Clear Aligner Marginal Termination Design (Supragingival vs Juxtagingival) on Aligner Color Stability After 14 Days of Wear: A Split-Mouth Study

* The goal of this clinical study is to learn whether the gumline edge design of a finishing orthodontic clear aligner affects how much the aligner's color changes after 14 days of wear. * The main question is: does a supragingival edge design - a straight edge covering about 2 mm of gum tissue - lead to a different amount of color change in the aligner compared with a juxtagingival edge design that follows the gumline exactly, after 14 days of wear? * Each participant wears finishing clear aligners with both edge designs at the same time - one design on the upper jaw and the other on the lower jaw - and serves as their own comparison (split-mouth). This within-person approach removes differences between individuals in oral hygiene, diet, and saliva. * The aligner's color over six selected teeth (three upper, three lower) is measured with a dental spectrophotometer (VITA Easyshade V) at placement (day 0) and after 14 days. Each measurement is repeated three times under standardized optical conditions. The amount of color change is expressed as a color-difference value (ΔE). * The study hypothesis is that marginal termination design (supragingival versus juxtagingival) is associated with a difference in the 14-day colorimetric change (ΔE00) of the finishing aligner. * The study is carried out during the finishing (refinement) stage of orthodontic treatment, when only small residual tooth movements remain, so that color changes can be attributed to wear and edge design rather than to tooth movement.

NCT Number	NCT07628491
Lead Sponsor	George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures Collaborators: Aorys Clinic, Sibiu, Romania, SC APARAT DENTAR SRL, Sibiu, Romania
Conditions	Malocclusion, Esthetics, Dental
Enrollment	50 participants
Start Date	2026-06-15
Primary Completion	2026-07-23 (estimated)
Study Completion	2026-07-23 (estimated)
Updated on ClinicalTrials.gov	2026-07-24